Administrative Supplements to NCI Grant
and Cooperative Agreement Awards to Support Collaborations with the PDX
Development and Trial Centers Research Network (PDXNet)(Admin Supp Clinical
Trial Not Allowed)

Activity Code

Administrative Supplement

Additional funds may be awarded as supplements to parent
awards using the following Activity Code(s):

Administrative supplement requests must be submitted on
paper for the following activity codes:

This administrative supplement funding opportunity
announcement is part of the Cancer Moonshot initiative to accelerate cancer
research, and was developed in response to a recommendation from the Blue
Ribbon Panel of experts charged with advising the National Cancer Advisory
Board on the exceptional scientific opportunities that could be accelerated
through this initiative. As part of the Cancer Moonshot initiative, the
National Cancer Institute (NCI) created the Patient-Derived Xenograft (PDX)
Development and Trial Centers Research Network (PDXNet), a collaborative
network of centers of excellence focused on using patient-derived xenografts
and other patient-derived models to accelerate the development of NCI
investigational new drug (IND) agents (i.e., those that the NCI is developing
in collaboration with pharmaceutical partners) in NCI-sponsored early phase
clinical trials. This FOA supports supplemental funds to current NCI-funded
research projects for new interdisciplinary collaborations between non-PDXNet
investigators and PDXNet investigators to perform research within the
scientific scope(s) of the parent grant and/or cooperative agreement award(s)
that will lead to improved pre-clinical evaluations of novel therapeutic
concepts using the large-scale PDX model collections of PDXNet, and that
could ultimately be tested in NCI-sponsored clinical trials.

Key Dates

Posted Date

December 15, 2017

Open Date (Earliest Submission Date)

January 30, 2018

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

March 1, 2018, by 5:00 PM local time of applicant
organization.

Applicants are encouraged to apply early to allow adequate
time to make any corrections to errors found in the application during the
submission process by the due date.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

Not Applicable

Advisory Council Review

Not Applicable

Earliest Start Date

May 2018

Expiration Date

March 2, 2018

Due Dates for E.O. 12372

Not Applicable

Required
Application Instructions

It is critical that applicants follow the instructions in
the Application Guide (SF424
(R&R) Application Guide, eRA
Commons Administrative Supplement User Guide or PHS 398
Application Guide, as appropriate) except
where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and
Contracts). Conformance to all requirements (both in the
Application Guide and the FOA) is required and strictly enforced. Applicants
must read and follow all application instructions in the Application Guide as
well as any program-specific instructions noted in Section IV. When the program-specific
instructions deviate from those in the Application Guide, follow the
program-specific instructions. Applications that do not comply with
these instructions may be delayed or not accepted for review.

The National Cancer Institute (NCI) established a Blue
Ribbon Panel to assist the National Cancer Advisory Board by providing expert
advice on the vision, proposed scientific goals, and

implementation of the Cancer Moonshot initiative. To meet
the goals of the Moonshot panel and to advance the concept of cancer precision
medicine, a collaborative network of centers of excellence focused on using
patient-derived xenografts (PDXs) and other patient-derived models was formed
to accelerate the development of NCI-IND investigational agents (agents NCI is
developing in collaboration with pharmaceutical partners) in NCI-sponsored
early phase clinical trials (PDXNet). Because PDXNet investigators have
valuable models and specialized expertise not usually accessible to most
investigators, NCI wanted to make the resources of these centers available to
other investigators to test their novel therapeutic concepts.

The research project proposed in the administrative
supplement should align with the overarching goal of PDXNet, which is to
develop pre-clinical data to support novel therapeutic concepts that have a
feasible path for clinical validation. Furthermore, each supplement request
must propose a collaborative project that is within the scope of work already
peer-reviewed and approved in the eligible parent awards.

BACKGROUND

The evaluation of novel anticancer therapies employing
patient-derived xenografts (PDXs) has the potential to increase the precision
of clinical treatment assignments by determining the effectiveness of such
therapies against more accurate representations of human cancers than
previously employed. Patient-derived models, such as PDXs and patient-derived
organoids (PDOs), that reflect human tumor biology more closely than
established cell lines due to their low passage number, offer the potential of
more predictive models than traditional cancer cell lines. When properly
derived and maintained, PDXs can provide a representative tumor screening
platform for both single agents and drug combinations.

As more targeted agents become available, and as more
refined tumor subtypes are defined, PDXs can help identify and prioritize the
optimal combination of agents to test in increasingly narrow tumor subsets in
early phase clinical trials. In addition, PDXs may assist in determining the
relationships between molecular characteristics or signatures of tumors and
therapeutic response with higher resolution and more efficiency (less cost) than
can be achieved in human clinical studies. Increasing the precision of cancer
therapy requires increasing the resolution of the assignment of therapy to
specific diagnoses. For example, PDX studies could potentially identify tumor
characteristics that are associated with beneficial response to investigational
anticancer drug regimens. PDX programs thus have the potential to provide a
path to much more precise assignments of either single agent or combination
treatment regimens in cancer therapy.

As part of the Cancer Moonshot initiative, NCI created
PDXNet, a network of centers of excellence that use PDX models on a large scale
to address the challenges of cancer precision medicine. PDXNet was formed in 2017,
with four PDX Development and Trial Centers (PDTCs)(U54) and one PDXNet Data
Commons and Coordinating Center (PDCCC)(U24) being funded in response to two
Requests For Applications (RFAs). The primary goal of the PDXNet is to develop
PDX trials that test therapeutic strategies in large scale PDX collections that
represent the relevant molecular diversity of particular histologies in a
context that can feasibly lead to clinical validation of the experimental
results. Of note, the PDX research projects in PDXNet are conducted in
immune-incompetent mice, and the testing of immuno-oncology strategies is not
included in the PDXNet program.

A secondary goal of the PDXNet is to build a PDX resource
that can be accessed by non-network investigators for rigorous PDX evaluation
of therapeutic concepts through competitive administrative supplement awards as
described below. Therefore, the goal of this solicitation is to provide
eligible investigators the opportunity to use PDXNet resources to advance
therapeutic concepts within the scopes of projects have already been peer
reviewed in applications and funded as grants and cooperative agreements.

It is anticipated that the awarded funds will be used to
support research at the applicant’s institution. It is anticipated that the
institutions awarded these funds will provide the necessary information
technology (IT) support structure to collaborate with the PDXNet. These will be
1-year supplements to eligible NCI-funded grant and cooperative agreement
awards only. Administrative supplement awardees may request a 1-year no-cost
extension. However, the project and budget periods of any administrative
supplement request must be within the currently approved project period for the
existing parent award. Additional administrative supplement funds will
separately be made available to one or more of the four PDTCs in the PDXNet to
cover the PDTC costs associated with the collaboration.

Expected
elements

This request for administrative supplements supports NCI’s
efforts to enhance the development of PDX models as a tool for precision
medicine that will guide cancer drug development and cancer therapy. Requests
may include the testing of novel therapeutic combinations in molecularly
defined tumor subsets, experiments that examine mechanisms of drug sensitivity
and resistance, and development of predictive biomarkers.

Scope
of Support

The funding mechanism being used to support this program,
administrative supplements, can be used to cover cost increases that are
associated with achieving certain augmented/enhanced research objectives as
long as they are within the original scope of the project and are related to
using PDX models to further pre-clinical development of anti-cancer therapies.
Any cost increases need to result from making modifications to the project in
order to take advantage of opportunities that would increase the value of the
project consistent with its originally approved objectives and purposes.

The research proposed under the administrative supplement
program must be within the original scope of the parent award. Applicants
should propose research that, if successful, would lead to incorporation of
anticancer agents or biomarkers into future novel clinical trials. The
following types of applications are considered to fall within the scope of this
program:

Studying mechanisms of intrinsic and acquired drug resistance as
well as exceptional therapeutic sensitivity; and

Identifying potential biomarkers that could be used to monitor or
select patients for therapy.

The administrative supplement is intended to promote
collaborations between PDXNet investigators and non-PDXNet investigators.
Therefore, the applicant(s) should both commit to a collaborative effort with
PDTC investigators in the proposed studies and expect that the proposed
research plan of an approved administrative supplement could be adjusted based
on input from the PDTC investigators. It is anticipated that preclinical
studies using the PDTC’s models would be performed at the PDTC, and that data
and relevant specimens, based on the applicant’s proposed research study, would
be sent to the awardee. Information regarding the PDX models that are available
at the existing (four) PDTCs can be found at https://www.pdxnetwork.org/supplemental-projects/.

The scope of proposed projects of the research plan should
fit within budget constraints of both the supplement award to the applicant and
the separate supplement award to the collaborating PDTC. It is anticipated that
the total costs for the administrative supplement for each collaborating PDTC
will be approximately equal to the total costs of the supplements awarded under
this announcement.

IC-Specific
Considerations

Applicants are strongly encouraged to discuss their proposed
supplement project with the NCI Program Official of the parent grant prior to
submission of a supplement application in order to ensure that the content area
of the supplement fits within the scientific priorities of the NCI and is
within the scope of the parent grant. In addition to contacting the NCI Program
Official for the parent grant, applicants are strongly encouraged to include
the Scientific/Research Contact person listed in Section VII. Agency Contacts in these communications.

Grant: A support mechanism providing money, property, or
both to an eligible entity to carry out an approved project or activity.

Cooperative Agreement: A support mechanism used when there
will be substantial Federal scientific or programmatic involvement. Substantial
involvement means that, after award, NIH scientific or program staff will
assist, guide, coordinate, or participate in project activities. See Section
VI.2 for additional information about the substantial involvement for this
FOA.

Application Types Allowed

Non-competing Administrative Supplements

Clinical Trial?

Not Allowed: Only accepting applications that do not propose
clinical trials.

The number of awards is contingent upon NIH appropriations
and the submission of a sufficient number of meritorious applications.

NCI intends to commit $500,000 in FY 2018 to fund four awards.

Award Budget

Application budgets are limited to no more than $125,000
total costs per year, regardless of the number of collaborating units. This
is exclusive of consortium costs and must reflect the actual needs of the
proposed project. The budget should not include the estimated expenses of the
collaborating PDTC.

The funding mechanism being used to support this program,
administrative supplements, can be used to cover cost increases that are
associated with achieving certain new research objectives, as long as the
research objectives are within the original scope of the peer reviewed and
approved project, or the cost increases are for unanticipated expenses within
the original scope of the project. Any cost increases need to result from
making modifications to the project that would increase or preserve the overall
impact of the project consistent with its originally approved objectives and
purposes.

Award Project Period

The project and budget periods must be within the
currently approved project period for the existing parent award. The budget
period must be for 1 year only.

NIH grants policies as
described in the NIH Grants
Policy Statement will apply
to the applications submitted and awards made from this FOA.

Section III. Eligibility
Information

1. Eligible Applicants

Eligible Organizations

All organizations administering an eligible parent award may
apply for a supplement under this announcement.

Higher Education Institutions

Public/State Controlled Institutions of Higher Education

Private Institutions of Higher Education

The following types of
Higher Education Institutions are always encouraged to apply for NIH support as
Public or Private Institutions of Higher Education:

This announcement is for supplements to existing projects.
To be eligible, the parent award must be active and the research proposed in
the supplement must be accomplished within the competitive segment. The
proposed supplement must be to provide for an increase in costs due to
unforeseen circumstances. All additional costs must be within the scope of the
peer reviewed and approved project.

IMPORTANT: The research proposed by the NIH grantee in the
supplement application must be within the original scope of the NIH-supported
grant project.

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are
not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Required Registrations

Applicant
Organizations

Applicant organizations must complete and maintain the
following registrations as described in the SF 424 (R&R) Application Guide
to be eligible to apply for or receive an award. Since administrative
supplements are made against active grants and cooperative agreements, many of
these registrations may already be in place. All registrations must be
completed prior to the application being submitted. Registration can take 6
weeks or more, so applicants should begin the registration process as soon as
possible. The NIH
Policy on Late Submission of Grant Applications states that failure to
complete registrations in advance of a due date is not a valid reason for a
late submission.

Dun and Bradstreet
Universal Numbering System (DUNS) - All registrations require that
applicants be issued a DUNS number. After obtaining a DUNS number, applicants
can begin both SAM and eRA Commons registrations. The same DUNS number must be
used for all registrations, as well as on the grant application.

System for Award Management (SAM) (formerly CCR) – Applicants must complete and maintain an active registration, which requires renewal at least
annually. The renewal process may require as much time as the
initial registration. SAM registration includes the assignment of a Commercial
and Government Entity (CAGE) Code for domestic organizations which have not
already been assigned a CAGE Code.

eRA Commons - Applicants
must have an active DUNS number and SAM registration in order to complete the
eRA Commons registration. Organizations can register with the eRA Commons as
they are working through their SAM or Grants.gov registration. eRA Commons
requires organizations to identify at least one Signing Official (SO) and at
least one Program Director/Principal Investigator (PD/PI) account in order to
submit an application.

Grants.gov – Applicants
must have an active DUNS number and SAM registration in order to complete the
Grants.gov registration. Grants.gov registration is only required if you plan
to submit using the 'Electronic Application Submission through Grants.gov'
option.

Program
Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account.
PD(s)/PI(s) should work with their organizational officials to either
create a new account or to affiliate their existing account with the applicant
organization in eRA Commons.If the PD/PI is also the organizational Signing
Official, they must have two distinct eRA Commons accounts, one for each role.
Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal
Investigator)

Individual(s) must hold an active grant or cooperative
agreement, and the research proposed in the supplement must be accomplished
within the competitive segment of the active award. Individuals are encouraged to
work with their organizations to develop applications for support.

For supplements to parent awards that include multiple PDs/PIs, the supplement
may be requested by any or all of the PDs/PIs (in accordance with the existing
leadership plan) and submitted by the awardee institution of the parent award. Do
not use this administrative supplement application to add, delete, or change
the PDs/PIs listed on the parent award. Visit the Multiple Program
Director/Principal Investigator Policy in the SF424 (R&R) Application Guide
for more information.

Applicant organizations may submit more than one application,
provided that each is sufficiently distinct from any other administrative
supplement currently under consideration by the awarding NIH Institute or Center.

Section IV. Application and
Submission Information

1. Requesting an
Application Package

Applicants must prepare applications using current forms in
accordance with the Application Guide.

Buttons to access the online ASSIST system or to download
application forms are available in Part
1 of this FOA. See your administrative office for instructions if you plan
to use an institutional system-to-system solution.

2. Content and Form of Application Submission

All forms must be completed for the supplemental activities only and must not reflect funding or activities for the previously awarded parent
award.

All page limitations applicable to the parent award as
described in the Application Guide and the Table of
Page Limits must be followed.

Application Submission

Administrative supplement requests for most single-project
activity codes can be submitted using either paper or electronic submission
processes. Administrative supplement requests for multi-project activity codes
must be submitted using the paper submission process. See Activity Code section
in Part 1 to determine if electronic submission is an option for your activity
code.

Use the “Apply” button(s) in Part I of this
announcement to access the application forms package posted at Grants.gov. If
presented with more than one form package, use the Competition ID and
Competition Titles provided to determine the most appropriate application forms
package for your situation.

Prepare applications using the SF424 (R&R) forms
associated with the chosen package. Please note that some forms marked optional
in the application package are required for submission of applications for this
announcement. Follow all instructions in the SF424 (R&R)
Application Guide to ensure you complete all appropriate required and
optional forms, with the following additional guidance:

R&R Cover form: Select “Revision” in the “Type of
Application” field.

Research Plan form: At a minimum, the Research Strategy section
should be completed and must include a summary or abstract of the funded parent
award or project. Other sections should also be included if they are being
changed by the proposed supplement activities, with the exception of Specific
Aims which are not required and will not be evaluated. The Research Strategy
should address, in separate sections, the bulleted items below:

· Summary
or abstract of the funded parent award or project.

· Description
of proposed research plan and its relationship to the parent project.

· Identification
of which of the four PDTCs in the PDXNet would be the proposed research
collaborator, and how the proposed research project will utilize the resources
of the proposed PDTC collaborator.

Project/Performance Site Location form: Include the primary site
where the proposed supplement activities will be performed. If a portion of the
proposed supplement activities will be performed at any other site(s), identify
the locations in the fields provided.

Sr/Key Personnel form: List the PD/PI as the first person
(regardless of their role on the supplement activities). List any other
Senior/Key Personnel who are being added through this supplement, or for whom
additional funds are being requested through this supplement; include a
biographical sketch for each.

R&R Other Project Information form: If applicable, attach PDF
documents in the “Other Attachments” field indicating that the proposed
research experience was approved by the Institutional Animal Care and Use
Committee (IACUC) or human subjects Institutional Review Board (IRB) at the
grantee institution. Name the documents “IACUC Documentation.pdf” and/or “IRB
Documentation.pdf”. Adherence to the NIH policy for including women and
minorities in clinical studies must also be ensured, if additional human
subjects’ involvement is planned for the supplement.

Special Instructions for Streamlined
Submissions using the eRA Commons for electronic-based submissions

NIH offers a streamlined system through the eRA Commons
for submitting administrative supplements. Login to the eRA Commons,
identify the parent award, and prepare an administrative supplement request. A User’s
Guide for submitting through this system is available, with the following
additional guidance:

R&R Cover form: Select “Revision” in the “Type of
Application” field.

Research Plan form: At a minimum, the Research Strategy section
should be completed and must include a summary or abstract of the funded parent
award or project. Other sections should also be included if they are being
changed by the proposed supplement activities, with the exception of Specific
Aims which are not required and will not be evaluated. The Research Strategy
should address, in separate sections, the bulleted items below:

· Summary
or abstract of the funded parent award or project.

· Description
of proposed research plan and its relationship to the parent project.

· Identification
of which of the four PDTCs in the PDXNet would be the proposed research
collaborator, and how the proposed research project will utilize the resources
of the proposed PDTC collaborator.

Project/Performance Site Location form: Include the primary site
where the proposed supplement activities will be performed. If a portion of the
proposed supplement activities will be performed at any other site(s), identify
the locations in the fields provided.

Sr/Key Personnel form: List the PD/PI as the first person
(regardless of their role on the supplement activities). List any other
Senior/Key Personnel who are being added through this supplement, or for whom
additional funds are being requested through this supplement; include a
biographical sketch for each.

Budget forms (e.g., R&R Budget, PHS 398 Training Budget):
Only include funds requested for the additional supplement activities. Budget
information should be entered for the grantee institution in the tabs provided
for each selected budget period. Since there is no template or form available
for subaward budget information, all subaward information must be included as a
PDF attachment in the Subrecipient Budgets section showing the funds requested
(by budget period) and using the same categories provided for the grantee
institution. The attachment must also include any related budget justification
information.

R&R Other Project Information form: If applicable, attach PDF
documents in the “Other Attachments” field indicating that the proposed
research experience was approved by the Institutional Animal Care and Use
Committee (IACUC) or human subjects Institutional Review Board (IRB) at the
grantee institution. Name the documents “IACUC Documentation.pdf” and/or “IRB
Documentation.pdf”. Adherence to the NIH policy for including women and
minorities in clinical studies must also be ensured, if additional human
subjects’ involvement is planned for the supplement.

Instructions for Paper-based Submissions using the PHS 398 Application Forms

Face Page (Form Page 1): On the face page of the application
form, note that your application is in response to a specific program
announcement, and enter the title and number of this announcement.

Research Plan: At a minimum, the Research Strategy section should
be completed and must include a summary or abstract of the funded parent award
or project. Other sections should also be included if they are being changed by
the proposed supplement activities, with the exception of Specific Aims which
are not required and will not be evaluated. The Research Strategy should
address, in separate sections, the bulleted items below:

· Summary
or abstract of the funded parent award or project.

· Description
of proposed research plan and its relationship to the parent project.

· Identification
of which of the four PDTCs in the PDXNet would be the proposed research
collaborator, and how the proposed research project will utilize the resources
of the proposed PDTC collaborator.

Project/Performance Sites section (Form Page 2): Include the
primary site where the proposed supplement activities will be performed. If a
portion of the proposed supplement activities will be performed at any other
site(s), identify the locations in the fields provided.

Sr/Key Personnel section (Form Page 2): List the PD/PI as the
first person (regardless of their role on the supplement activities). List any
other Senior/Key Personnel who are being added through this supplement, or for
whom additional funds are being requested through this supplement; include a
biographical sketch for each.

Budget for Entire Proposed Project Period (Form Page 5): A
proposed budget should be submitted using the PHS 398 budget forms and should
only include funds requested for the additional supplement activities.

If applicable, attach documentation in the Appendix section
indicating that the proposed research experience was approved by the
Institutional Animal Care and Use Committee (IACUC) or human subjects
Institutional Review Board (IRB) at the grantee institution. Adherence to the
NIH policy for including women and minorities in clinical studies must also be
ensured, if additional human subjects’ involvement is planned for the
supplement component.

The grantee institution, on behalf of the PD/PI of
the parent award, must submit the request for supplemental funds directly to
the awarding component that supports the parent award. Submit a signed,
typewritten original of the application, including the checklist, to:

See Part 1. Section III.1 for information regarding the
requirement for obtaining a unique entity identifier and for completing and
maintaining active registrations in System for Award Management (SAM), NATO
Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and
Grants.gov.

4. Submission Dates and
Times

Part I. Overview Information contains information about Key Dates and Times. Applicants are encouraged to
submit electronic applications before the due date to ensure they have time to
make any application corrections that might be necessary for successful
submission. When a submission date falls on a weekend or Federal
holiday, the application deadline is automatically extended to the next
business day.

Applicants
are responsible for viewing their electronic application before the due date in
the eRA Commons to ensure accurate and successful submission.

For electronic application submission, information on the
submission process and a definition of on-time submission are provided in the SF424(R&R)
Application Guide.

For paper-based application
submission, information on the process of receipt and determining if your
application is considered on-time is described in detail in the PHS 398
Application Guide.

For assistance with your electronic application or for more information on the electronic submission
process, visit Applying
Electronically. If you encounter a system issue beyond your control that
threatens your ability to complete the submission process on-time, you must
follow the Guidelines
for Applicants Experiencing System Issues. For assistance with application
submission contact the Application Submission Contacts in Section VII.

Important
reminders:For applications submitted electronically on the SF424
(R&R) Application forms, all PD(s)/PI(s) must include their eRA Commons ID
in the Credential field of the Senior/Key Person Profile form of the SF
424(R&R) Application Package. Failure to register in the Commons and to
include a valid PD/PI Commons ID in the credential field will prevent the
successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS
number it provides on the application is the same number used in the
organization’s profile in the eRA Commons and for the (SAM). Additional
information may be found in the Application Guide.

Administrative Supplements do not receive peer review. Instead,
the administrative criteria described below will be considered in the administrative
evaluation process.

The staff of the NIH awarding component will evaluate
requests for a supplement to determine its overall merit. The following general
criteria will be used:

Budget and
Period of Support

NIH staff will consider whether the
budget and the requested period of support are fully justified and reasonable
in relation to the proposed research.

Overall Impact

NIH staff will consider the ability of the proposed
supplement activities to increase or preserve the parent award’s overall impact
within the original scope of award:

Will the administrative supplement increase or preserve the
likelihood for the project to exert a sustained, powerful influence on the
research field(s) involved?

How well does the administrative supplement define the cancer
problem to be addressed, including the tumor histology of the PDX models, the
anticipated subtypes of the PDX models, and the potential for using the PDX
models to answer a significant clinically-relevant question?

How well does the administrative supplement request explain why
PDXNet resources are required to accomplish the research objectives?

Does the administrative supplement application contain relevant
preliminary data in support of the proposed research project?

Does the approach separate the work to be done at the applicant’s
laboratory and the work proposed for the specified PDTC within the PDXNet? (Note:
The collaboration can include any one of the PDTCs in the PDXNet.)

Does the administrative supplement application describe a
feasible path to clinical validation of the proposed project’s research
findings?

In addition, each of the following criteria will be evaluated
as applicable for the proposed supplement.

Protections for Human Subjects:

For research that involves human
subjects but does not involve one of the six categories of research that are
exempt under 45 CFR Part 46, NIH staff will evaluate the justification for
involvement of human subjects and the proposed protections from research risk
relating to their participation according to the following five review
criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3)
potential benefits to the subjects and others, 4) importance of the knowledge
to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human
subjects and meets the criteria for one or more of the six categories of
research that are exempt under 45 CFR Part 46, NIH staff will evaluate: 1) the
justification for the exemption, 2) human subjects involvement and
characteristics, and 3) sources of materials. For additional information on
review of the Human Subjects section, please refer to the Guidelines
for the Review of Human Subjects.

Inclusion of Women, Minorities,
and Children

When the proposed project involves
human subjects and/or NIH-defined clinical research, the committee will
evaluate the proposed plans for the inclusion (or exclusion) of individuals on
the basis of sex/gender, race, and ethnicity, as well as the inclusion (or
exclusion) of children to determine if it is justified in terms of the
scientific goals and research strategy proposed. For additional information on
review of the Inclusion section, please refer to the Guidelines
for the Review of Inclusion in Clinical Research.

Vertebrate Animals

NIH staff will evaluate the
involvement of live vertebrate animals as part of the scientific assessment
according to the following five points: (1) description of
proposed procedures involving animals, including species, strains, ages, sex,
and total number to be used; (2) justifications for the use of animals versus
alternative models and for the appropriateness of the species proposed; (3)
interventions to minimize discomfort, distress, pain and injury; and (4)
justification for euthanasia method if NOT consistent with the AVMA Guidelines
for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as
they would any other application proposing the use of vertebrate animals. For
additional information on review of the Vertebrate Animals section, please
refer to the Worksheet
for Review of the Vertebrate Animal Section.

Biohazards

NIH staff will assess whether
materials or procedures proposed are potentially hazardous to research
personnel and/or the environment, and if needed, determine whether adequate
protection is proposed.

2. Review and Selection
Process

Administrative supplement requests will undergo an
administrative evaluation by NIH staff, but not a full peer review. Applications
submitted for this funding opportunity will be assigned to the awarding
component for the parent award and will be administratively evaluated using the
criteria shown above.

3. Anticipated Announcement and Award Dates

Not Applicable

Section VI. Award
Administration Information

1. Award Notices

A formal notification in the form of a Notice of Award (NoA)
will be provided to the applicant organization for successful applications.
This may be as an NoA for the supplemental activities only; alternatively, it
may be as either a revision to the current year NoA or included as part of a
future year NoA. The NoA signed by the grants management officer is the
authorizing document and will be sent via email to the grantee’s business
official.

Awardees must comply with any funding restrictions described
in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be
subject to terms and conditions found on the Award
Conditions and Information for NIH Grants website. This includes any
recent legislation and policy applicable to awards that is highlighted on this
website. When calculating the award for additional funds, NIH will 1) prorate
funding if the requested budget period is adjusted at the time of award, and 2)
use the institution’s current F&A rate; i.e., the rate in effect when the
new funding is provided.

Recipients of federal financial
assistance (FFA) from HHS must administer their programs in compliance with
federal civil rights law. This means that recipients of HHS funds must ensure
equal access to their programs without regard to a person’s race, color,
national origin, disability, age and, in some circumstances, sex and religion.
This includes ensuring your programs are accessible to persons with limited
English proficiency. HHS recognizes that research projects are often limited
in scope for many reasons that are nondiscriminatory, such as the principal
investigator’s scientific interest, funding limitations, recruitment
requirements, and other considerations. Thus, criteria in research protocols that
target or exclude certain populations are warranted where nondiscriminatory
justifications establish that such criteria are appropriate with respect to the
health or safety of the subjects, the scientific study design, or the purpose
of the research.

For additional guidance regarding how the provisions apply
to NIH grant programs, please contact the Scientific/Research Contact that is
identified in Section VII under Agency Contacts of this FOA. HHS provides
general guidance to recipients of FFA on meeting their legal obligation to take
reasonable steps to provide meaningful access to their programs by persons with
limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html.
The HHS Office for Civil Rights also provides guidance on complying with civil
rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html;
and http://www.hhs.gov/ocr/civilrights/understanding/index.html.
Recipients of FFA also have specific legal obligations for serving qualified
individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.
Please contact the HHS Office for Civil Rights for more information about
obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS
Departmental goal to ensure access to quality, culturally competent care,
including long-term services and supports, for vulnerable populations. For
further guidance on providing culturally and linguistically appropriate
services, recipients should review the National Standards for Culturally and
Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

In accordance with the statutory
provisions contained in Section 872 of the Duncan Hunter National Defense
Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be
subject to the Federal Awardee Performance and Integrity Information System
(FAPIIS) requirements. FAPIIS requires Federal award making officials to
review and consider information about an applicant in the designated integrity
and performance system (currently FAPIIS) prior to making an award. An
applicant, at its option, may review information in the designated integrity
and performance systems accessible through FAPIIS and comment on any
information about itself that a Federal agency previously entered and is
currently in FAPIIS. The Federal awarding agency will consider any comments by
the applicant, in addition to other information in FAPIIS, in making a
judgement about the applicant’s integrity, business ethics, and record of
performance under Federal awards when completing the review of risk posed by
applicants as described in 45 CFR Part 75.205 “Federal awarding agency review
of risk posed by applicants.” This provision will apply to all NIH grants and
cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

Any supplements to Cooperative Agreements will be subject to
the same Cooperative Agreement terms and conditions as the parent award.

3. Reporting

Reporting requirements will be specified in the terms and
conditions of award as applicable to the supplemental activities. In most non-competing
continuation applications, the progress report and budget for the supplement
must be included with, but clearly delineated from, the progress report and
budget for the parent award. The progress report must include information about
the activities supported by the supplement even if support for future years is
not requested. Continuation of support for the supplement activities in the
remaining years of the competitive segment of the grant will depend upon
satisfactory review by the NIH awarding component of progress for both the parent
award and the supplement project, the research proposed for the next budget
period, and the appropriateness of the proposed budget for the proposed effort.
This information is submitted with the Research Performance
Progress Report (RPPR) and financial statements as required in the NIH Grants
Policy Statement.

The Federal Funding Accountability and Transparency Act of
2006 (Transparency Act), includes a requirement for awardees of Federal grants
to report information about first-tier subawards and executive compensation
under Federal assistance awards issued in FY2011 or later. All awardees of
applicable NIH grants and cooperative agreements are required to report to
the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants
Policy Statement for additional information on this reporting
requirement.

In accordance with the regulatory requirements provided at
45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have
currently active Federal grants, cooperative agreements, and procurement
contracts from all Federal awarding agencies with a cumulative total value
greater than $10,000,000 for any period of time during the period of performance
of a Federal award, must report and maintain the currency of information
reported in the System for Award Management (SAM) about civil, criminal,
and administrative proceedings in connection with the award or performance of a
Federal award that reached final disposition within the most recent five-year
period. The recipient must also make semiannual disclosures regarding
such proceedings. Proceedings information will be made publicly available
in the designated integrity and performance system (currently FAPIIS). This is
a statutory requirement under section 872 of Public Law 110-417, as amended (41
U.S.C. 2313). As required by section 3010 of Public Law 111-212, all
information posted in the designated integrity and performance system on or after
April 15, 2011, except past performance reviews required for Federal
procurement contracts, will be publicly available. Full reporting requirements
and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and
Conditions for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.